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Sareum Share Chat (SAR)



Share Price: 0.44Bid: 0.43Ask: 0.45Change: 0.00 (0.00%)No Movement on Sareum
Spread: 0.02Spread as %: 4.65%Open: 0.465High: 0.465Low: 0.44Yesterday’s Close: 0.44


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Hopkirk
Posts: 1,122
Off Topic
Opinion:No Opinion
Price:0.48
MHRA guidelines for Clinical Trials
27 Mar '14
If anyone is interested, here are the UK guidelines for what needs to happen on CHK1 before trials start...

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Applyingforaclinicaltrialauthorisation/Additionalinformation/

On the shelf-life side it states that a 3 month real time test period can be used to extrapolate that it will be OK for 12 months of shelf life. This is probably the minimum that they will go for, given that trials could take that long.

I'm not sure how they test this. It could be some sort of molecular analysis or maybe repeating the initial toxicology tests after the 3 months is up.

Either way, it gives an indication of the ongoing work that needs to be done to support the paperwork for initiating trials.

GLA
Hopkirk
Posts: 1,122
Off Topic
Opinion:No Opinion
Price:0.50
50sBoy
26 Mar '14
I could be wrong but thats the way I see it
50sBoy
Posts: 323
Off Topic
Opinion:No Opinion
Price:0.50
Hopkirk
26 Mar '14
Appreciated, so as we have heard nothing we can assume things are progressing along nicely on both fronts..
Hopkirk
Posts: 1,122
Off Topic
Opinion:No Opinion
Price:0.50
50sBoy
26 Mar '14
I'm fine thanks. Looking forward to the next 12 months here.

We are in the final stages of Pre-Clinical development (both here for CHK1 and China for Aurora FLT3).

The main things to prove are detailed toxicology on aminals (more than just the mice which have been successfully tested on so far) and manufacture of the drugs in sufficient quantity and quality to be used on people (right down to packaging) and also shelf-life tests (does it degrade after a certain period of time). I'm not sure if these are running concurrently but given the high cost of this work it wouldn't suprise me.

Failure at any point would be market sensitive info and should be notified as soon as they know. But I doubt that we will be informed of each little success until all of the pre-clinical work is complete. He could say "we are 95% of the way through, just one little step to go" only for that little step to scupper the whole thing.

IMO we should get notified when pre-clinical is finished and the paperwork is submitted for trials to start. But for CHK1 and Aurora FLT3 that should be in the second half of this year.

Either one actually being used on people would be a great success. Both would be amazing. It's one of the benefits of SAR over other companies in my opinion.

But the question of funding the CHK1 trials remains. Shorter term, its a gamble. If Tim can deal on something else, it takes away this doubt. If he doesn't SAR will need to find over a million to pay for the trials (if the payment is similar to BACITs and probably is) which will not be kind to the SP.

Fingers crossed for a) Pre-Clinical success and then b) funding. Not necessarily in that order.

GLA
50sBoy
Posts: 323
Off Topic
Opinion:No Opinion
Price:0.50
Hopkirk
26 Mar '14
Regarding your post yesterday, would it not be beneficial for Sar to inform us as to how things are progressing throughout this period. Not sure as to what is considered the norm. (if it is allowed or not)
Hope you are well, and keep up the good research work.
mountaingoat
Posts: 12
Off Topic
Opinion:No Opinion
Price:0.50
timehh!
26 Mar '14
come on timmehhhhhhh!
moons
Posts: 2,465
Observation
Opinion:No Opinion
Price:0.49
tick up
26 Mar '14
not far away..to 0.50-0.55
elgouna
Posts: 173
Answer
Opinion:No Opinion
Price:0.49
paulus47
26 Mar '14
i agree with you ,, i will accumulate at this price even if the mm but lower no problem for us ,,even the next weeks or months we are long term player here ,,,look to you invested from 2004 ,,, the price was much higher than now for me is prefect play if the mm play longer low ,
enyaw1
Posts: 158
Premium Chat Member
Off Topic
Opinion:No Opinion
Price:0.49
sar
26 Mar '14
make that point lol



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